[Hiring] Clinical Research Specialist @Medtronic

Role Description

As one of three comprehensive portfolios at Medtronic, Neuroscience is dedicated to improving the lives of people living with neurological disorders, spine conditions, and chronic pain. Guided by our Mission—to alleviate pain, restore health, and extend life—we develop technologies and therapies that help people regain function, reduce pain, and return to the activities that matter most.

The Clinical Research Specialist supports clinical evidence strategy across the product lifecycle, with a primary focus on leading New Product Innovation (NPI) clinical evidence generation activities and managing Post‑Market Clinical Follow‑up (PMCF) activities in accordance with EU MDR requirements. This is a strategy‑driven role, responsible for clinical evidence planning, execution, assessment, and documentation. The position does not perform day‑to‑day clinical operations but works closely with Clinical Operations and cross‑functional teams across the Cranial & Spinal Technologies (CST) operating unit to ensure clinical data collection activities are aligned with regulatory and business needs.

Responsibilities may include the following and other duties may be assigned:

• Lead clinical evidence strategy for the CST portfolio, including development and maintenance of Global Clinical Evidence Strategy (GCES) documentation aligned to business needs.
• Develop, maintain, and periodically revise PMCF Plans in accordance with EU MDR Annex XIV; assess evidence sufficiency and execute PMCF activities (surveys, registries, observational studies) to close identified gaps.
• Integrate PMCF outputs into CERs and related documentation; evaluate the impact of incremental product changes on PMCF strategy.
• Partner with Clinical Operations on PMCF study design, and with Medical Writing on CEPs, CERs, PMCFRs, and SSCPs.
• Collaborate with Regulatory Affairs, Quality, R&D, Medical Affairs, and Marketing on submissions, post-market assessments, and claims substantiation.
• Support responses to Notified Body and regulatory authority inquiries; support surgeon engagements as needed.
• Maintain strategic oversight of PMCF activities and ensure all documentation remains current, traceable, and audit-ready.

Qualifications

• Baccalaureate degree
• Minimum of 2 years of relevant experience, or an advanced degree with 0 years of experience.

Requirements

• Experience with EU MDR PMCF activities (nice to have)
• Familiarity with medical device clinical documentation (PMCF, CER, CEP)
• Exposure to regulatory or audit support
• Strong cross‑functional collaboration skills
• High level of attention to detail in regulated environments
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Benefits

• Competitive Salary and flexible Benefits Package
• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Incentive plans
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)